Kornimate/medical-research-clean huggingface dataset:
the cohort study for asthma in china

Conditions: Asthma, Bronchial

Summary: the study is to establish a standardized asthma cohort study, build an information network platform system and a biospecimen bank for asthma cohort, establish clear follow-up standards and norms, observe the asthma outcomes and identify biomarkers to predict asthma outcomes.

this is a single center observational prospective longitudinal cohort study to establish a standardized asthma cohort, consisting of 400 patients with asthma. baseline data including lung function test, chest ct, induced sputum, etc. was collected and the patients were followed up for 2 or more years. subjects who met the 2023 gina diagnostic criteria for asthma and were able to participate in the study according to the protocol and sign the informed consent were included. no additional investigational drugs will be applied to the patients. blood samples are transported to designated laboratories for safekeeping and biomarker testing. we aimed to explore the mechanism of biomarkers involved in asthma pathogenesis and identify treatable traits related to disease outcome. full analysis set will be used for all analyses. missing data will be analyzed as it is. statistical analysis will be conducted by epidemiology \& statistics work group from chinese academy of sciences, using sas and sudaan software. an electronic data capture system will be used in this study. paper-based questionnaire administration will also be used. questionnaire variables will be checked before data entry. during the study, pi will be in charge of the monitoring of the whole procedure. working group will do the data cleaning and data analyzing.

Eligibility criteria:
inclusion criteria: * age \>18 * meet the 2023 edition of gina asthma diagnostic criteria * subjects must sign informed consent prior to study participation, participate in the study according to the protocol and follow up for 2 years exclusion criteria: * suffering from other massive lung tissue destructive diseases such as severe bronchiectasis and tuberculosis * severe pleural disease and/or sternal and rib lesions * serious uncontrolled disease of other system * thoracic or abdominal surgery in the past 3 months * eye surgery in the past three months * retina detachment * myocardial infarction within the last 3 months * hospitalized for heart disease within the past 3 months * ongoing anti-tuberculosis treatment * pregnancy or breast feeding
reduced pain after bariatric surgery - sleeve gastrectomy

Conditions: Pain; Postoperative Pain; Acute Pain; Analgesia; Bariatric Surgery Candidate; Anesthesia

Summary: this study aims to analyze the effect of laparoscopic guided transversus abdominis plane (lg-tap) block compared to placebo for postoperative analgesia following laparoscopic sleeve gastrectomy. one group of participants received a (lg-tap) block with local anesthetic while the other group received (lg-tap) block with saline solution (placebo).


Eligibility criteria:
inclusion criteria: * elective laparoscopic sleeve gastrectomy * body mass index (bmi) \> 35 kg/m² and at least one condition related to obesity (e.g., hypertension, type ii diabetes, dyslipidemia, hepatic steatosis, etc) * bmi \> 40 kg/m², even in the absence of comorbidities * asa physical status score \< 4 exclusion criteria: * asa physical status score ≥ 4 * patient's refusal or inability to sign the informed consent * allergies to any drug provided by the study protocol
creation of an ecg database in 3t mri with healthy heart and several kind of cardiac disease.

Conditions: Heart Diseases

Summary: the aim is to create a database including recordings of ecg data recorded in an mri acquisition

ecg monitoring is an essential tool during mri, especially for cardiac mri (cmr). indeed, the system needs to synchronize the acquisitions on the cardiac cycles. to identify the cycle, the system is based on the ecg. furthermore, patients having a cmr can be at risk of presenting cardiac rhythm troubles, and must be monitored with a trustable system. the problem is that in mri, a lot of artefacts occur, leading to dramatic disturbances of the signal. a lot of tools are used to try to remove the artefacts. the aim of this study is to create a database that can be used to test the different tools to remove the artefacts. the investigators intend to include all types of ecg patterns that can exist, to allow to test the tools in all situations.

Eligibility criteria:
inclusion criteria: * for all subjects: * to be more than 18 * to be enroled in a social security plan * to have signed an informed consent * to have preliminary medical examination * for the groups : * "normal ecg" group : sinus rhythm without conductive troubles. normal pattern of the qrs * "conductive troubles group" : patients with typical right bundle branch block, or typical left bundle branch block pattern. * "rhythm trouble group" : patients with premature atrial beats or premature ventricular beats exclusion criteria: * contraindication: implantable devices (cardiac stimulators, defibrillators, cochlear implants, etc.), metallic foreign bodies * impossibility to undergo mri: claustrophobia, morbid obesity. * pregnancy or risk of pregnancy. * patients under a measure of legal protection

Keywords: ecg mri rhythm troubles conductive troubles ecg artifacts database
coagulation parameters in postmenopausal breast cancer patients under adjuvant hormonal therapy

Conditions: Breast Cancer

Summary: the objective of the study is to monitor the changes of blood coagulation parameters in postmenopausal patients who are treated with adjuvant hormonal therapy for a total of 5 years. the values of the standard coagulation parameters throughout the study will be compared with the baseline values.

study subjects will be treated with standard adjuvant hormonal therapy for a total of 5 years or until disease relapse or until ht is permanently discontinued for other reasons. the choice of endocrine treatment strategy (drugs to be used or their sequence, if the sequential option has been decided) is left at the discretion of the participating site. adjuvant ht will commence after the completion of adjuvant chemotherapy and/or radiotherapy. percentage change (%) from baseline of the blood coagulation parameters at 6, 12, 18, and 24 months of treatment. the blood coagulation parameters which will be measured are fibrinogen, prothrombin time (pt) and activated partial thromboplastin time (aptt).

Eligibility criteria:
inclusion criteria: * postmenopausal status. er and/or pgr status positive. adjuvant hormonal treatment for 5 years according to standard practice has been decided by the treating physician. values within normal limits for the blood coagulation parameters at baseline visit. accessible for follow-up for the duration of the trial. written informed consent. exclusion criteria: * both er and pgr negative primary tumor. evidence of distant metastases (m1) neo-adjuvant hormonotherapy. chronic use of oral anticoagulants such as warfarin or acenocoumarol. psychiatric disorders preventing proper informed consent. concomitant malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal squamous cell carcinoma of the skin.

Keywords: aromatase inhibitors coagulation parameters tamoxifen
clinical and live birth rates after following long antagonist protocol versus long agonist protocol

Conditions: Pregnancy, Ovarian

Summary: a prospective study of the evaluation of the clinical ivf (in vitro fertilization) results after following long antagonist protocol for controlled ovarian stimulation (cos) versus following long agonist protocol

a prospective study of the clinical results in women who followed the long antagonist protocol for controlled ovarian stimulation (cos) versus women who followed long agonist protocol, in an in vitro fertilization (ivf) try. in particular, the clinical pregnancy rates (cpr) and live birth rates (lbr) were estimated for the two groups of patients. the number of the formed blastocysts was also measured in each group of patients.

Eligibility criteria:
inclusion criteria: * primary infertility * age 18-39 years; body mass index (bmi) 18-29kg/m2; * regular menstrual cycle of 26-35days, * presumed to be ovulatory; * early follicular- phase serum concentration of fsh within normal limits (1-12 iu/l). exclusion criteria: * women with diabetes and other metabolic disease * women with heart disease, qt prolongation,heart failure * elevated liver enzymes, liver failure, hepatitis * women with inflammatory or autoimmune disease * abnormal karyotype; * polycystic ovarian syndrome, * endometriosis stage iii/iv; * history of being a 'poor responder', * defined as \>20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe ohss in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins.

Keywords: long antagonist long agonist clinical pregnancy rate live birth rate ovarian stimulation ivf
healthy, immunized communities study

Conditions: Vaccine Hesitancy; Communicable Diseases in Children

Summary: this project aims to understand how improving vaccine education and awareness can impact the number of parents who vaccinate, or intend to vaccine, their middle school-aged children with age-appropriate vaccines, including human papillomavirus (hpv), meningitis (mcv) and tetanus, diphtheria, pertussis (tdap).

vaccines are considered one of the greatest public health successes. unfortunately, an increasing rate of parental resistance in recent years has led to a reemergence of vaccine-preventable diseases. this project seeks to determine the effect of a multi-tiered school and community-based approach to improving rates of parental intent to vaccinate for middle school-aged vaccinations including human papillomavirus (hpv), meningitis (mcv) and tetanus, diphtheria, pertussis (tdap). by randomizing participating schools, parents receiving the intervention participated in (1) a community-based event to raise parental awareness of the importance of vaccination and (2) a social marketing campaign targeting parents' attitudes and knowledge around vaccinations. the investigators hypothesized that participation in this study would increase parental intention to vaccinate. in addition, this study intended to improve rates of recommended vaccination among middle school-aged children, as measured through vaccine uptake information required for annual entry into pennsylvania public schools. the penn state team brings a breadth of experience in pediatrics, community-engaged research, adolescent health, and engagement with schools.

Eligibility criteria:
inclusion criteria * 18 years or older * parents and guardians of children who attend a school district of lancaster middle schools * individuals who read and understand english * individuals with an email address exclusion criteria * individuals who are non-english speaking * parents/guardians \<18 years or older who do not have children attending a middle school in the school district of lancaster * individuals who do not have an email address * individuals who plan on moving out of the lancaster city area in the next year

Keywords: vaccinations vaccine hesitancy school-based research
study to investigate the pharmacodynamic effect of a single dose of azd2516 in healthy male subjects

Conditions: Reflux

Summary: the purpose of this study is to investigate the pharmacodynamic effect of azd2516 in healthy male subjects.

a double-blind, randomized, placebo-controlled, two-centre, phase iia pharmacodynamic cross-over study to assess the effect of azd2516 on the total number of reflux episodes in healthy male volunteers.

Eligibility criteria:
inclusion criteria: * provision of signed informed consent * healthy male subjects * age 18-45 years, inclusive exclusion criteria: * clinically significant illness within the 2 weeks prior to the first dose of study drug * history of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal disease * need for concomitant medications during the study

Keywords: pharmacodynamic effect reflux inhibition
penicillin allergy de-labelling in elective surgical patients (padles)

Conditions: Allergy

Summary: penicillin antibiotics are safe and inexpensive, and target selected bacteria rather than killing a broad range. unfortunately, around 10% of the population are labelled as 'penicillin allergic'. this is often based on side effects such as rash and diarrhoea, and 90-95% of people with the label are not actually allergic to the drug. the label leads to the use of alternative antibiotics, which tend to more toxic, and less specific about which bacteria they kill; this increases the risk of infections with so-called 'super-bugs', compared to patients without the label. people with the label also have an increased length of hospital stay and rates of readmission. these are significant problems for individuals, as well as wider society. where the diagnosis is in doubt, the gold standard test for allergy is an oral challenge. patients undergo skin +/- blood tests prior to a challenge, as these can help make the diagnosis. this combined pathway is expensive and time consuming, so testing cannot be offered routinely to all patients. however in patients with 'historic' reactions (many years previously), skin and blood tests become much less useful; in one study, 100% of patients who skin tested positive for amoxycillin allergy, tested negative 5 years later. patients with historic reactions can therefore proceed directly to an oral challenge without prior skin or blood testing, since these offer little help in making the diagnosis. this streamlines the pathway, making it quick, non-invasive and cheap. already established practice in several centres in europe and beyond, this abbreviated pathway is offered on an ad-hoc basis in some centres in the uk. the aim is to demonstrate that this pathway offers a safe and effective way to perform large-scale delabelling of elective surgical patients, who might not otherwise meet nice criteria for testing.


Eligibility criteria:
inclusion criteria: * allergic history is historic (more than 10 years ago) and suggestive of a non-immediate reaction or side effect * requires penicillin as first-line treatment for their planned surgery * \>18 years * willing and able to give consent exclusion criteria: * not willing to participate * history suggestive of immediate type reaction (anaphylaxis) * history of toxic epidermal necrolysis or stevens johnson syndrome * pregnant, planning to become pregnant during study, or breastfeeding
atorvastatin in active vitiligo

Conditions: Vitiligo

Summary: condition: non segmental and active vitiligo of adulthood. main objective: to evaluate the efficacy of a daily treatment with atorvastatin 80mg/d combined to uvb compared to uvb alone in active vitiligo after 6 months of treatment. methods: prospective interventional bicentric study with evaluation blinded to the treatment received. inclusion criteria: patients from 18 to 75 year-old with active non segmental vitiligo. active is defined by the apparition or the modification of vitiligo lesions with the past 3 months and under wood's lamp examination hypochromic borders and/or spotty depigmentation. interventions: after central randomization * arm a : atorvastatin 40mg/d for 1 months then 80mg/d for 5 months combined with twice weekly narrowband uvb treatment for 6 months. * arm b: with twice weekly narrowband uvb treatment for 6 months. evaluation: main criteria: decrease of vasi score expressed in percentage secondary criteria: decrease of vetf score expressed in percentage. variation of pga and dlqi scores. clinical and biological tolerance. variation of cxcl10 levels in the serum. length of the study: inclusion period: 12 months. length of treatment: 6 months. statistical analyses and drafting the article: 6 months. total length: 24 months.


Eligibility criteria:
inclusion criteria: * active non-segmental vitiligo defined by * non- segmental vitiligo with new patches or extension of old lesions during the last 3 months and * presence of hypochromic aspect under wood's lamp examination and/or perifollicular hypopigmentation under wood's lamp examination * patient requiring a treatment by uvb * signed informed consent document * patient registered to the french social security exclusion criteria: * - segmental or mixed vitiligo * pregnant (urinary pregnancy test will be done) or lactating patients * allergy to statin medications * use of statin or fibrate medications due to cardiac risks * use of statin medications in the past 8 weeks * use of any medications contraindicated with use of statin medications * use of vitiligo treatments (both topicals and phototherapy) in the past 4 weeks * treatment with immunomodulating oral medications in the past 4 weeks * hepatic disease and/or dysfunction * renal dysfunction * personal or familial history of myopathy or personal history of rhabdomyolysis or elevated baseline creatinine kinase * alcohol or drug abuse * untreated hypothyroidism * personal history of skin cancer * any other clinically significant findings that, in the opinion of the principal investigator, might interfere with study evaluations or pose a risk to subject safety during the study. * patients assessed to be uncooperative * participants in other clinical studies
study of at-777 in healthy subjects and at-777 in combination with at-527 in hcv-infected subjects

Conditions: Hepatitis C; Hepatitis C, Chronic; Chronic Hepatitis C; Hepatitis C Virus Infection; HCV Infection

Summary: this study has two parts. part a will assess the safety, tolerability and pharmacokinetics (pk) of at-777 in healthy subjects. part b will assess the safety, antiviral activity/efficacy and pk of at-777 in combination with at-527 after 8 weeks of treatment in hcv-infected subjects.


Eligibility criteria:
inclusion criteria: all: * body mass index (bmi) of 18-35 kg/m2 * must agree to use protocol-specified methods of contraception * negative pregnancy test * willing to comply with the study requirements and to provide written informed consent additional for part a: -18-55 years of age additional for part b: * 18-65 years of age * hcv genotype 1, 2 or 3 * documented history compatible with chronic hepatitis c * hcv rna ≥ 10,000 iu/ml at screening exclusion criteria: all: * pregnant or breastfeeding * abuse of alcohol or drugs * use of other investigational drugs within 30 days of dosing * other clinically significant medical conditions additional for part b: * prior exposure to any hcv ns5a inhibitor * cirrhosis * co-infection with hepatitis b virus or hiv
delta radiomics for liver function evaluation

Conditions: Chronic Liver Disease

Summary: to evaluate the feasibility and efficacy of delta radiomics-derived index based on gd-eob-dtpa enhanced mri as a new imaging biomarker for the quantitative assessment of liver function.

delta radiomics is a novel concept proposed on the basis of radiomics. it can be used to evaluate the dynamic changes of imaging features in the time dimension, reflecting functional information of the tissue. in clinical practice, liver function can be evaluated by gadoxate enhanced mri by measuring signal intensity. most often, simple visual assessment is performed, but quantitative measurements are also done. theoretically, liver function should also be possible to quantify by using delta radiomics, ie by subtracting mr imaging features obtained in the earlier phase from the latter phase.

Eligibility criteria:
inclusion criteria: * 18-70 years old, no gender limit. * patients with chronic liver disease and different degrees of liver damage (child-pugh a, b and c) and healthy controls. * no history of liver-related surgery (except for cholecystectomy). * no cardiopulmonary diseases or other diseases which may impair liver function. * agree to participate in the study and provide written informed consent. exclusion criteria: * alcoholic hepatitis, non-alcoholic fatty liver disease, or autoimmune hepatitis. * liver tumors or metastasis or other extraheptic tumor. * splenectomy or other cases where the spleen is absent. * chronic kidney disease, renal damage. * allergy to contrast agents or other conditions that cannot undergo gd-eob-dtpa enhanced mri exam.

Keywords: liver function magnetic resonance imaging radiomics chronic liver disease quantitative assement
addition of ondansetron to ongoing antipsychotic treatment for schizophrenia

Conditions: Schizophrenia

Summary: this study will examine the effects of ondansetron on auditory nerve activity in people with schizophrenia who are being treated with new antipsychotics.

schizophrenia is a devastating brain disorder. most people with schizophrenia have difficulty filtering out unimportant auditory information. they have an inability to appropriately inhibit, or gate, sensory information that enters the ear. standard treatments do not address this problem. when the drug ondansetron is taken in addition to typical antipsychotic drugs, p50 auditory gating improves. however, ondansetron has not been used with some of the newer, atypical antipsychotic drugs. this study will evaluate the effect of combining ondansetron with newer, atypical antipsychotic drugs on p50 auditory gating. participants in this double-blind study will be randomly assigned to receive either ondansetron or placebo for 3 months. upon completion of the first 3 months, participants will be crossed over to receive the other treatment for an additional 3 months. all participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole. auditory gating will be assessed using computerized cognitive testing and functional magnetic resonance imaging (fmri) at baseline and months 3 and 6. vital signs and evoked potentials will be assessed at weeks 1, 3, and 6. clinical symptoms and cognitive abilities will also be evaluated to determine the effectiveness of ondansetron.

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for schizophrenia * stable, chronic schizophrenia * currently taking atypical medications * use of effective form of contraception throughout study exclusion criteria: * history of any alcohol or drug abuse within 3 months of study start date * any other major neurological disorders * history of or current head trauma * any medical conditions affecting the central nervous system * current epilepsy, asthma, migraine headache, previous myocardial infarction, stroke, diabetes, hypertension, narrow angle glaucoma, or neuromuscular illnesses * pregnant

Keywords: schizophrenia ondansetron p50 sensory gating evoked potentials 5-ht3 receptors atypical antipsychotics